Section H. Pharmaceuticals. Pharmaceutical Schedule. Effective 1 July for Hospital. Update effective 1 January 2016

Transcription

1 The Hospital Medicines List (HML) Section H for Hospital Pharmaceuticals Pharmaceutical Management Agency Update effective 1 January 2016 Update New Cumulative Zealand for December 2015 and January 2016 Pharmaceutical Schedule Effective 1 July 2013 Cumulative for May, June and July 2013

2 Contents Summary of decisions effective 1 January Section H changes to Part II... 5 Index

3 Summary of decisions EFFECTIVE 1 JANUARY 2016 Adalimumab (Humira) inj 10 mg per 0.2 ml prefilled syringe new listing Adalimumab inj 20 mg per 0.4 ml syringe and inj 40 mg per 0.8 ml syringe (Humira) and inj 40 mg per 0.8 ml pen (HumiraPen) price decrease Amoxicillin (Ospamox) grans for oral liq 125 mg per 5 ml and 250 mg per 5 ml new listing Aqueous cream (AFT SLS-free) crm 500 g new listing and addition of HSS Aqueous cream (AFT) crm 500 g to be delisted 1 March 2016 Bleomycin sulphate (DBL Bleomycin Sulfate) inj 15,000 iu vial amended presentation description Chloramphenicol (Chlorsig) eye oint 1%, 4 g price increase Ciprofloxacin (Cipflox) inj 2 mg per ml, 100 ml bag new listing and addition of HSS Ciprofloxacin (Aspen Ciprofloxacin) inj 2 mg per ml, 100 ml bag to be delisted 1 March 2016 Extensively hydrolysed formula (e.g. Aptamil Gold+ Pepti Junior) powder 14 g protein, 53.4 g carbohydrate and 27.3 g fat per 100 g, 450 g can amended restriction Ezetimibe (Ezemibe) tab 10 mg packaging and Pharmacode change Glycerin with sodium saccharin (Ora-Sweet SF) suspension price decrease Glycerin with sucrose (Ora-Sweet) suspension price decrease Icatibant (Firazyr) inj 10 mg per ml, 3 ml prefilled syringe new listing Infliximab (Remicade) inj 100 mg amended restriction Isotretinoin cap 10 mg (Isotane 10) and cap 20 mg (Isotane 20) HSS suspended Isotretinoin (Oratane) cap 10 mg and 20 mg new listing Mesalazine (Asacol) tab 800 mg new listing Methylcellulose (Ora-Plus) suspension price decrease Methylcellulose with glycerin and sodium saccharin (Ora-Blend SF) suspension price decrease Methylcellulose with glycerin and sucrose (Ora-Blend) suspension price decrease Mixed salt solution for eye irrigation (Balanced Salt Solution) eye irrigation solution calcium chloride 0.048% with magnesium chloride 0.03%, potassium chloride 0.075%, sodium acetate 0.39%, sodium chloride 0.64% and sodium citrate 0.17%, 500 ml bottle Pharmacode change 3

4 Summary of decisions effective 1 January 2016 (continued) Oxaliplatin (Oxaliccord) inj 5 mg per ml, 10 ml and 20 ml vials new listing and addition of HSS Oxaliplatin inj 50 mg vial (Oxaliplatin Actavis 50) and 100 mg vial (Oxaliplatin Actavis 100) to be delisted 1 March 2016 Rifampicin (Rifadin) tab 600 mg to be delisted 1 March 2016 Sumatriptan (Arrow-Sumatriptan) inj 12 mg per ml, 0.5 ml cartridge HSS suspended Valaciclovir (Vaclovir) tab 500 mg and 1,000 mg new listing and addition of HSS Valaciclovir (Valtrex) tab 500 mg to be delisted 1 March 2016 Ziprasidone (Zusdone) cap 20 mg, 40 mg, 60 mg and 80 mg restriction removed 4 All decisions related to news items are effective from 1 January unless otherwise indicated

5 Price Brand or Section H changes to Part II Effective 1 January 2016 ALIMENTARY TRACT AND METABOLISM 14 MESALAZINE (new listing) Tab 800 mg Asacol CARDIOVASCULAR SYSTEM 44 EZETIMIBE (Pharmacode change) Tab 10 mg 1% DV Aug-15 to Ezemibe Note Pharmacode change from a blister pack to bottle. The blister will be delisted from 1 July DERMATOLOGICALS 50 ISOTRETINOIN (HSS suspended) Cap 10 mg 1% DV Nov-15 to 31/12/ Isotane 10 Cap 20 mg 1% DV Nov-15 to 31/12/ Isotane ISOTRETINOIN (new listing) Cap 10 mg Oratane Cap 20 mg Oratane 51 AQUEOUS CREAM Crm 500 g 1% DV Mar-16 to g AFT SLS-free Note: DV limit applies to the pack sizes of greater than 100 g. Note AFT aqueous cream 500 g to be delisted from 1 March INFECTIONS 72 AMOXICILLIN (new listing) Grans for oral liq 125 mg per 5 ml ml Ospamox Grans for oral liq 250 mg per 5 ml ml Ospamox 73 CIPROFLOXACIN Inj 2 mg per ml, 100 ml bag 1% DV Mar-16 to Cipflox Note Aspen Ciprofloxacin inj 2 mg per ml, 100 ml bag to be delisted from 1 March RIFAMPICIN (discontinuation) Tab 600 mg 1% DV Nov-14 to Rifadin Note Rifadin tab 600 mg to be delisted from 1 March VALACICLOVIR Tab 500 mg 1% DV Mar-16 to Vaclovir Tab 1,000 mg 1% DV Mar-16 to Vaclovir Note Valtrex tab 500 mg to be delisted from 1 March Products with Hospital Supply Status (HSS) are in bold. Expiry date of HSS period is 30 June of the year indicated unless otherwise stated. 5

6 Price Brand or Changes to Section H Part II effective 1 January 2016 (continued) NERVOUS SYSTEM 116 SUMATRIPTAN (HSS suspended) Inj 12 mg per ml, 0.5 ml cartridge 1% DV Sep-13 to 31/12/ Arrow-Sumatriptan 120 ZIPRASIDONE (restriction removed) Cap 20 mg 1% DV Jan-16 to Zusdone Cap 40 mg 1% DV Jan-16 to Zusdone Cap 60 mg 1% DV Jan-16 to Zusdone Cap 80 mg 1% DV Jan-16 to Zusdone 1 Patient is suffering from schizophrenia or related psychoses; and 2 Either: 2.1 An effective dose of risperidone or quetiapine has been trialled and has been discontinued, or is in the process of being discontinued, because of unacceptable side effects; or 2.2 An effective dose of risperidone or quetiapine has been trialled and has been discontinued, or is in the process of being discontinued, because of inadequate clinical response. ONCOLOGY AGENTS AND IMMUNOSUPPRESSANTS 128 BLEOMYCIN SULPHATE (amended presentation description) Inj 15,000 iu (10 mg) vial 1% DV Oct-15 to DBL Bleomycin Sulfate 133 OXALIPLATIN Inj 5 mg per ml, 10 ml vial 1% DV Mar-16 to Oxaliccord Inj 5 mg per ml, 20 ml vial 1% DV Mar-16 to Oxaliccord Note Oxaliplatin Actavis 50 inj 50 mg vial and Oxaliplatin Actavis 100 inj 100 mg vial to be delisted from 1 March ADALIMUMAB (new listing) Inj 10 mg per 0.2 ml prefilled syringe...1, Humira 147 ADALIMUMAB ( price) Inj 20 mg per 0.4 ml syringe...1, Humira Inj 40 mg per 0.8 ml pen...1, HumiraPen Inj 40 mg per 0.8 ml syringe...1, Humira 154 INFLIXIMAB (amended restriction affected criteria only) Inj 100 mg 10% DV Mar-15 to 29 Feb Remicade Initiation fistulising Crohn s disease Gastroenterologist Re-assessment required after 4 months Therapy limited to 4 doses 1 Patient has confirmed Crohn s disease; and 2 Either: 2.1 Patient has one or more complex externally draining enterocutaneous fistula(e); or 2.2 Patient has one or more rectovaginal fistula(e). Initiation plaque psoriasis, prior TNF use 6 Restriction (Brand) indicates a brand example only. It is not a contracted product.

7 Price Brand or Changes to Section H Part II effective 1 January 2016 (continued) Dermatologist Re-assessment required after Therapy limited to 3 doses Either: The patient has had an initial Special Authority approval for adalimumab or etanercept for severe chronic plaque psoriasis; and 1.2 Either: The patient has experienced intolerable side effects from adalimumab or etanercept; or The patient has received insufficient benefit from adalimumab or etanercept to meet the renewal criteria for adalimumab or etanercept for severe chronic plaque psoriasis; or Either: Patient has whole body severe chronic plaque psoriasis with a Psoriasis Area and Severity Index (PASI) score of greater than 15, where lesions have been present for at least 6 months from the time of initial diagnosis; or Patient has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and 2.2 Patient has tried, but had an inadequate response (see Note) to, or has experienced intolerable side effects from, at least three of the following (at maximum tolerated doses unless contraindicated): phototherapy, methotrexate, ciclosporin, or acitretin; and 2.3 A PASI assessment has been completed for at least the most recent prior treatment course (but preferably all prior treatment courses), preferably while still on treatment but no longer than 1 month following cessation of each prior treatment course; and 2.4 The most recent PASI assessment is no more than 1 month old at the time of initiation. Note: Inadequate response is defined as: for whole body severe chronic plaque psoriasis, a PASI score of greater than 15, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment; for severe chronic plaque psoriasis of the face, hand or foot, at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe, and the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment. Initiation plaque psoriasis, treatment-naive Dermatologist Therapy limited to 3 doses 1 Either: 1.1 Patient has whole body severe chronic plaque psoriasis with a Psoriasis Area and Severity Index (PASI) score of greater than 15, where lesions have been present for at least 6 months from the time of initial diagnosis; or 1.2 Patient has severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and 2 Patient has tried, but had an inadequate response (see Note) to, or has experienced intolerable side effects from, at least three of the following (at maximum tolerated doses unless contraindicated): phototherapy, thotrexate, ciclosporin, or acitretin; and 3 A PASI assessment has been completed for at least the most recent prior treatment course (but preferably all prior treatment courses), preferably while still on treatment but no longer than 1 month following cessation of each prior treatment course; and 4 The most recent PASI assessment is no more than 1 month old at the time of initiation. Products with Hospital Supply Status (HSS) are in bold. Expiry date of HSS period is 30 June of the year indicated unless otherwise stated. 7

8 Price Brand or Changes to Section H Part II effective 1 January 2016 (continued) Note: Inadequate response is defined as: for whole body severe chronic plaque psoriasis, a PASI score of greater than 15, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment; for severe chronic plaque psoriasis of the face, hand or foot, at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe, and the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably while still on treatment but no longer than 1 month following cessation of the most recent prior treatment. RESPIRATORY SYSTEM AND ALLERGIES 172 ICATIBANT (new listing) Inj 10 mg per ml, 3 ml prefilled syringe...2, Firazyr Initiation Clinical immunologist or relevant specialist Re-assessment required after 12 months 1 Supply for anticipated emergency treatment of laryngeal/oro-pharyngeal or severe abdominal attacks of acute hereditary angioedema (HAE) for patients with confirmed diagnosis of C1-esterase inhibitor deficiency; and 2 The patient has undergone product training and has agreed upon an action plan for self-administration. Continuation Re-assessment required after 12 months The treatment remains appropriate and the patient is benefiting from treatment. SENSORY ORGANS 178 CHLORAMPHENICOL ( price) Eye oint 1% g Chlorsig 180 MIXED SALT SOLUTION FOR EYE IRRIGATION (Pharmacode change) Eye irrigation solution calcium chloride 0.048% with magnesium chloride 0.03%, potassium chloride 0.075%, sodium acetate 0.39%, sodium chloride 0.64% and sodium citrate 0.17%, 500 ml bottle 1% DV Jan-16 to ml Balanced Salt Solution Note Pharmacode change from to Pharmacode to be delisted from 1 January EXTEMPORANEOUSLY COMPOUNDED PREPARATIONS 193 GLYCERIN WITH SODIUM SACCHARIN ( price) Suspension ml Ora-Sweet SF 193 GLYCERIN WITH SUCROSE ( price) Suspension ml Ora-Sweet 193 METHYLCELLULOSE ( price) Suspension ml Ora-Plus 8 Restriction (Brand) indicates a brand example only. It is not a contracted product.

9 Price Brand or Changes to Section H Part II effective 1 January 2016 (continued) 193 METHYLCELLULOSE WITH GLYCERIN AND SODIUM SACCHARIN ( price) Suspension ml Ora-Blend SF 193 METHYLCELLULOSE WITH GLYCERIN AND SUCROSE ( price) Suspension ml Ora-Blend SPECIAL FOODS 203 EXTENSIVELY HYDROLYSED FORMULA Powder 14 g protein, 53.4 g carbohydrate and 27.3 g fat per 100 g, 450 g can e.g. Aptamil Gold+ Pepti Junior Initiation - new patients Any of the following: Cows milk formula is inappropriate due to severe intolerance or allergy to its protein content; and 1.2 Either: Soy milk formula has been reasonably trialled without resolution of symptoms; or Soy milk formula is considered clinically inappropriate or contraindicated; or 2 Severe malabsorption; or 3 Short bowel syndrome; or 4 Intractable diarrhoea; or 5 Biliary atresia; or 6 Cholestatic liver diseases causing malsorption; or 7 Cystic fibrosis; or 8 Proven fat malabsorption; or 9 Severe intestinal motility disorders causing significant malabsorption; or 10 Intestinal failure; or 11 For step down from Amino Acid Formula. Note: A reasonable trial is defined as a 2-4 week trial, or signs of an immediate IgE mediated allergic reaction. Initiation - step down from amino acid formula 1 The infant is currently receiving funded amino acid formula; and 2 The infant is to be trialled on, or transitioned to, an extensively hydrolysed formula. Continuation 1 An assessment as to whether the infant can be transitioned to a cows milk protein or soy infant formula has been undertaken; and 2 The outcome of the assessment is that the infant continues to require an extensively hydrolysed infant formula. Products with Hospital Supply Status (HSS) are in bold. Expiry date of HSS period is 30 June of the year indicated unless otherwise stated. 9

10 Changes to Section H Part II effective 1 December 2015 ALIMENTARY TRACT AND METABOLISM Price Brand or 24 NYSTATIN (new listing) Oral liquid 100,000 u per ml 1% DV Feb-16 to ml m-nystatin Note Nilstat oral liquid 100,000 u per ml to be delisted from 1 February NYSTATIN ( price and delisting) Decision recinded Oral liquid 100,000 u per ml ml Nilstat BLOOD AND BLOOD FORMING ORGANS 31 RIVAROXABAN (amended restriction) Tab 10 mg Xarelto Either: 1 Limited to five weeks treatment for the prophylaxis of venous thromboembolism following a total hip replacement; or 2 Limited to two weeks treatment for the prophylaxis of venous thromboembolism following a total knee replacement. Initiation total hip replacement Therapy limited to 5 weeks For the prophylaxis of venous thromboembolism. Initiation total knee replacement Therapy limited to 2 weeks For the prophylaxis of venous thromboembolism. INFECTIONS 73 DEMECLOCYCLINE HYDROCHLORIDE (new listing) Tab 150 mg 73 MOXIFLOXACIN (amended restriction) Tab 400 mg Avelox Inj 1.6 mg per ml, 250 ml bottle Avelox IV 400 Initiation Mycobacterium infection Infectious disease specialist, clinical microbiologist or respiratory specialist Either: Active tuberculosis; and, with 1.2 any of the following: Documented resistance to one or more first-line medications; or Suspected resistance to one or more first-line medications (tuberculosis assumed to be contracted in an area with known resistance), as part of regimen containing other second-line agents; or Impaired visual acuity (considered to preclude ethambutol use); or Significant pre-existing liver disease or hepatotoxicity from tuberculosis medications; or Significant documented intolerance and/or side effects following a reasonable trial of first-line medications; or 10 Restriction (Brand) indicates a brand example only. It is not a contracted product.

11 Price Brand or 2 Mycobacterium avium-intracellulare complex not responding to other therapy or where such therapy is contraindicated. Initiation Pneumonia Infectious disease specialist or clinical microbiologist Either: 1 Immunocompromised patient with pneumonia that is unresponsive to first-line treatment; or 2 Pneumococcal pneumonia or other invasive pneumococcal disease highly resistant to other antibiotics. Initiation Penetrating eye injury Ophthalmologist Five days treatment for patients requiring prophylaxis following a penetrating eye injury. Initiation Mycoplasma genitalium 1 Has nucleic acid amplification test (NAAT) confirmed Mycoplasma genitalium; and 2 Has tried and failed to clear infection using azithromycin; and 3 Treatment is only for 7 days. 85 ADEFOVIR DIPIVOXIL (amended restriction) Tab 10 mg Hepsera Gastroenterologist or infectious disease specialist 1 Patient has confirmed Hepatitis B infection (HBsAg+); and Documented resistance to lamivudine, defined as: 21 Patient has raised serum ALT (> 1 ULN); and 32 Patient has HBV DNA greater than 100,000 copies per ml, or viral load 10-fold over nadir; and 43 Detection of M204I or M204V mutation; and 54 Either: Patient is cirrhotic; and Adefovir dipivoxil to be used in combination with lamivudine; or Patient is not cirrhotic; and Adefovir dipivoxil to be used as monotherapy. 89 VALACICLOVIR (amended restriction) Tab 500 mg Valtrex Initiation Immunocompetent patients Any of the following: 1 Patient has genital herpes with 2 or more breakthrough episodes in any 6 month period while treated with aciclovir 400 mg twice daily; or 2 Patient has previous history of ophthalmic zoster and the patient is at risk of vision impairment; or 3 Patient has undergone organ transplantation. Initiation Immunocompromised patients Limited to 7 days treatment 1 Patient is immunocompromised; and 2 Patient has herpes zoster. Products with Hospital Supply Status (HSS) are in bold. Expiry date of HSS period is 30 June of the year indicated unless otherwise stated. 11

12 Price Brand or 90 PEGYLATED INTERFERON ALFA-2A (amended restriction) Inj 135 mcg prefilled syringe Inj 135 mcg prefilled syringe (4) with ribavirin tab 200 mg (112) Inj 135 mcg prefilled syringe (4) with ribavirin tab 200 mg (168) Inj 180 mcg prefilled syringe Pegasys Inj 180 mcg prefilled syringe (4) with ribavirin tab 200 mg (112)...1, Pegasys RBV Combination Pack Inj 180 mcg prefilled syringe (4) with ribavirin tab 200 mg (168)...1, Pegasys RBV Combination Pack Initiation Chronic hepatitis C genotype 1, 4, 5 or 6 infection or co-infection with HIV or genotype 2 or 3 post liver transplant Therapy limited to 48 weeks 1 Any of the following: 1.1 Patient has chronic hepatitis C, genotype 1, 4, 5 or 6 infection; or 1.2 Patient has chronic hepatitis C and is co-infected with HIV; or 1.3 Patient has chronic hepatitis C genotype 2 or 3 and has received a liver transplant. 2 Maximum of 48 weeks therapy. Notes: Consider stopping treatment if there is absence of a virological response (defined as at least a 2-log reduction in viral load) following 12 weeks of treatment since this is predictive of treatment failure. Consider reducing treatment to 24 weeks if serum HCV RNA level at Week 4 is undetectable by sensitive PCR assay (less than 50IU/ml) AND Baseline serum HCV RNA is less than 400,000IU/ml. Continuation (Chronic hepatitis C genotype 1 infection) Gastroenterologist, infectious disease specialist or general physician Therapy limited to 48 weeks 1 Patient has chronic hepatitis C, genotype 1; and 2 Patient has had previous treatment with pegylated interferon and ribavirin; and 3 Either: 3.1 Patient has responder relapsed; or 3.2 Patient was a partial responder; and 4 Patient is to be treated in combination with boceprevir; and 5 Maximum of 48 weeks therapy. Initiation (Chronic Hepatitis C genotype 1 infection treatment more than 4 years prior) Gastroenterologist, infectious disease specialist or general physician Therapy limited to 48 weeks 1 Patient has chronic hepatitis C, genotype 1; and 2 Patient has had previous treatment with pegylated interferon and ribavirin; and 3 Any of the following: 3.1 Patient has responder relapsed; or 3.2 Patient was a partial responder; or 3.3 Patient received interferon treatment prior to 2004; and 4 Patient is to be treated in combination with boceprevir; and 5 Maximum of 48 weeks therapy. 12 Restriction (Brand) indicates a brand example only. It is not a contracted product.

13 Price Brand or Initiation Chronic hepatitis C genotype 2 or 3 infection without co-infection with HIV Therapy limited to 6 months 1 Patient has chronic hepatitis C, genotype 2 or 3 infection; and 2 Maximum of 6 months therapy. Initiation Hepatitis B Gastroenterologist, infectious disease specialist or general physician Therapy limited to 48 weeks 1 Patient has confirmed Hepatitis B infection (HBsAg positive for more than 6 months); and 2 Patient is Hepatitis B treatment-naive; and 3 ALT > 2 times Upper Limit of Normal; and 4 HBV DNA < 10 log10 IU/ml; and 5 Either: 5.1 HBeAg positive; or 5.2 Serum HBV DNA 2,000 units/ml and significant fibrosis ( Metavir Stage F2 or moderate fibrosis); and 6 Compensated liver disease; and 7 No continuing alcohol abuse or intravenous drug use; and 8 Not co-infected with HCV, HIV or HDV; and 9 Neither ALT nor AST > 10 times upper limit of normal; and 10 No history of hypersensitivity or contraindications to pegylated interferon; and 11 Maximum of 48 weeks therapy. Notes: Approved dose is 180 mcg once weekly. The recommended dose of Pegylated Interferon alfa-2a is 180 mcg once weekly. In patients with renal insufficiency (calculated creatinine clearance less than 50ml/min), Pegylated Interferon alfa-2a dose should be reduced to 135 mcg once weekly. In patients with neutropaenia and thrombocytopaenia, dose should be reduced in accordance with the datasheet guidelines. Pegylated Interferon alfa-2a is not approved for use in children. MUSCULOSKELETAL SYSTEM 92 ALENDRONATE SODIUM (amended restriction) Tab 40 mg Fosamax Initiation Paget s disease 1 Paget s disease; and 2 Any of the following: 2.1 Bone or articular pain; or 2.2 Bone deformity; or 2.3 Bone, articular or neurological complications; or 2.4 Asymptomatic disease, but risk of complications due to site (base of skull, spine, long bones of lower limbs); or 2.5 Preparation for orthopaedic surgery. Products with Hospital Supply Status (HSS) are in bold. Expiry date of HSS period is 30 June of the year indicated unless otherwise stated. 13

14 Price Brand or 92 ALENDRONATE SODIUM (amended restriction affected criterion only) Tab 70 mg Fosamax Initiation Osteoporosis Any of the following: 1 History of one significant osteoporotic fracture demonstrated radiologically and documented bone mineral density (BMD) 2.5 standard deviations below the mean normal value in young adults (i.e. T-Score -2.5) (see Note); or 2 History of one significant osteoporotic fracture demonstrated radiologically, and either the patient is elderly, or densitometry scanning cannot be performed because of major logistical, technical or pathophysiological reasons. It is unlikely that this provision would apply to many patients under 75 years of age; or 3 History of two significant osteoporotic fractures demonstrated radiologically; or 4 Documented T-Score -3.0 (see Note); or 5 A 10-year risk of hip fracture 3%, calculated using a published risk assessment algorithm (e.g. FRAX or Garvan) which incorporates BMD measurements (see Note); or 6 Patient has had a Special Authority approval for zoledronic acid (underlying cause osteoporosis) or raloxifene. 93 ALENDRONATE SODIUM WITH CHOLECALCIFEROL (amended restriction affected criterion only) Tab 70 mg with cholecalciferol 5,600 iu Fosamax Plus Initiation Osteoporosis Any of the following: 1 History of one significant osteoporotic fracture demonstrated radiologically and documented bone mineral density (BMD) 2.5 standard deviations below the mean normal value in young adults (i.e. T-Score -2.5) (see Note); or 2 History of one significant osteoporotic fracture demonstrated radiologically, and either the patient is elderly, or densitometry scanning cannot be performed because of major logistical, technical or pathophysiological reasons. It is unlikely that this provision would apply to many patients under 75 years of age; or 3 History of two significant osteoporotic fractures demonstrated radiologically; or 4 Documented T-Score -3.0 (see Note); or 5 A 10-year risk of hip fracture 3%, calculated using a published risk assessment algorithm (e.g. FRAX or Garvan) which incorporates BMD measurements (see Note); or 6 Patient has had a Special Authority approval for zoledronic acid (underlying cause osteoporosis) or raloxifene. 97 TERIPARATIDE (amended restriction) Inj 250 mcg per ml, 2.4 ml cartridge Forteo Limited to 18 months treatment 1 The patient has severe, established osteoporosis; and 2 The patient has a documented T-score less than or equal to -3.0 (see Notes); and 3 The patient has had two or more fractures due to minimal trauma; and 4 The patient has experienced at least one symptomatic new fracture after at least 12 months continuous therapy with a funded antiresorptive agent at adequate doses (see Notes). Notes: 1 The bone mineral density (BMD) measurement used to derive the T-score must be made using dual-energy x-ray absorptiometry (DXA). Quantitative ultrasound and quantitative computed tomography (QCT) are not acceptable 2 Antiresorptive agents and their adequate doses for the purposes of this restriction Special Authority 14 Restriction (Brand) indicates a brand example only. It is not a contracted product.

15 Price Brand or are defined as: alendronate sodium tab 70 mg or tab 70 mg with cholecalciferol 5,600 iu once weekly; raloxifene hydrochloride tab 60 mg once daily; zoledronic acid 5 mg per year. If an intolerance of a severity necessitating permanent treatment withdrawal develops during the use of one antiresorptive agent, an alternate antiresorptive agent must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. 3 A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. 100 MELOXICAM (amended restriction) Tab 7.5 mg Either: 1 Haemophilic arthropathy, with both of the following: Haemophilic arthropathy; and The patient has moderate to severe haemophilia with less than or equal to 5% of normal circulating functional clotting factor; and Pain and inflammation associated with haemophilic arthropathy is inadequately controlled by alternative funded treatment options, or alternative funded treatment options are contraindicated; or 2 For preoperative and/or postoperative use for a total of up to 8 days use. NERVOUS SYSTEM 103 DESFLURANE (Pharmacode change) Soln for inhalation 100%, 240 ml bottle...1, Suprane Note Suprane bottle presentation changed, so Pharmacode change from to Pharmacode to be delisted from 1 February OXYCODONE HYDROCHLORIDE Inj 10 mg per ml, 1 ml ampoule 1% DV Feb-16 to OxyNorm Inj 10 mg per ml, 2 ml ampoule 1% DV Feb-16 to OxyNorm Note Oxycodone Orion inj 10 mg per ml, 1 ml and 2 ml ampoules to be delisted from 1 February GABAPENTIN (amended restriction affected criteria only) Cap 100 mg Arrow-Gabapentin Neurontin Nupentin Cap 300 mg Arrow-Gabapentin Neurontin Nupentin Cap 400 mg Arrow-Gabapentin Neurontin Nupentin 1 For preoperative and/or postoperative use for up to a total of 8 days use; or 2 For the pain management of burns patients with monthly review. Initiation preoperative and/or postoperative use Therapy limited to 8 days Initiation pain management of burns patients Re-assessment required after 1 month Products with Hospital Supply Status (HSS) are in bold. Expiry date of HSS period is 30 June of the year indicated unless otherwise stated. 15

16 Price Brand or Continuation pain management of burns patients Re-assessment required after 1 month The treatment remains appropriate and the patient is benefiting from the treatment. 115 VIGABATRIN (amended restriction) Tab 500 mg Initiation Re-assessment required after 15 months 1 Either: 1.1 Patient has infantile spasms; or Patient has epilepsy; and Either: Seizures are not adequately controlled with optimal treatment with other antiepilepsy agents; or Seizures are controlled adequately but the patient has experienced unacceptable side effects from optimal treatment with other antiepilepsy agents; and 2 Either: 2.1 Patient is, or will be, receiving regular automated visual field testing (ideally before starting therapy and on a 6-monthly basis thereafter); or 2.2 It is impractical or impossible (due to comorbid conditions) to monitor the patient s visual fields. Notes: Optimal treatment with other antiepilepsy agents is defined as treatment with other antiepilepsy agents which are indicated and clinically appropriate for the patient, given in adequate doses for the patient s age, weight, and other features affecting the pharmacokinetics of the drug with good evidence of compliance. Vigabatrin is associated with a risk of irreversible visual field defects, which may be asymptomatic in the early stages. Continuation 1 The patient has demonstrated a significant and sustained improvement in seizure rate or severity and or quality of life; and 2 Either: 2.1 Patient is receiving regular automated visual field testing (ideally every 6 months) on an ongoing basis for duration of treatment with vigabatrin; or 2.2 It is impractical or impossible (due to comorbid conditions) to monitor the patient s visual fields. Notes: As a guideline, clinical trials have referred to a notional 50% reduction in seizure frequency as an indicator of success with anticonvulsant therapy and have assessed quality of life from the patient s perspective. Vigabatrin is associated with a risk of irreversible visual field defects, which may be asymptomatic in the early stages. 116 PIZOTIFEN (new listing) Tab 500 mcg 1% DV Sep-15 to Sandomigran Note this is the listing of the bottle presentation. The blister pack also remains listed. 16 Restriction (Brand) indicates a brand example only. It is not a contracted product.

17 Price Brand or 124 DEXAMFETAMINE SULFATE (amended restriction) Tab 5 mg 1% DV Dec-15 to PSM Initiation ADHD Paediatrician or psychiatrist Patient has ADHD (Attention Deficit and Hyperactivity Disorder), diagnosed according to DSM-IV or ICD 10 criteria Initiation Narcolepsy Neurologist or respiratory specialist Re-assessment required after 24 months Patient suffers from narcolepsy Continuation Narcolepsy Neurologist or respiratory specialist Re-assessment required after 24 months The treatment remains appropriate and the patient is benefiting from the treatment. 125 METHYLPHENIDATE HYDROCHLORIDE (amended restriction affected criteria only) Tab extended-release 18 mg Concerta Tab extended-release 27 mg Concerta Tab extended-release 36 mg Concerta Tab extended-release 54 mg Concerta Tab immediate-release 5 mg Rubifen Tab immediate-release 10 mg Ritalin Rubifen Tab immediate-release 20 mg Rubifen Tab sustained-release 20 mg Rubifen SR Ritalin SR Cap modified-release 10 mg Ritalin LA Cap modified-release 20 mg Ritalin LA Cap modified-release 30 mg Ritalin LA Cap modified-release 40 mg Ritalin LA Initiation Narcolepsy (immediate-release and sustained-release formulations) Neurologist or respiratory specialist Re-assessment required after 24 months Patient suffers from narcolepsy. Continuation Narcolepsy (immediate-release and sustained-release formulations) Neurologist or respiratory specialist Re-assessment required after 24 months The treatment remains appropriate and the patient is benefiting from the treatment. 125 MODAFINIL (amended restriction) Tab 100 mg Initiation Neurologist or respiratory specialist Re-assessment required after 24 months 1 The patient has a diagnosis of narcolepsy and has excessive daytime sleepiness associated with narcolepsy occurring almost daily for three months or more; and 2 Either: Products with Hospital Supply Status (HSS) are in bold. Expiry date of HSS period is 30 June of the year indicated unless otherwise stated. 17

18 Price Brand or 2.1 The patient has a multiple sleep latency test with a mean sleep latency of less than or equal to 10 minutes and 2 or more sleep onset rapid eye movement periods; or 2.2 The patient has at least one of: cataplexy, sleep paralysis or hypnagogic hallucinations; and 3 Either: 3.1 An effective dose of a listed formulation of methylphenidate or dexamphetamine has been trialled and discontinued because of intolerable side effects; or 3.2 Methylphenidate and dexamphetamine are contraindicated. Continuation Narcolepsy Neurologist or respiratory specialist Re-assessment required after 24 months The treatment remains appropriate and the patient is benefiting from the treatment. ONCOLOGY AGENTS AND IMMUNOSUPPRESSANTS 128 DOXORUBICIN HYDROCHLORIDE (new listing) Inj 2 mg per ml, 25 ml vial 1% DV Feb-16 to Doxorubicin Ebewe Inj 2 mg per ml, 50 ml vial 1% DV Feb-16 to Doxorubicin Ebewe Inj 2 mg per ml, 100 ml vial 1% DV Feb-16 to Doxorubicin Ebewe Note Arrow-Doxorubicin inj 2 mg per ml, 25 ml and 100 ml vials to be delisted from 1 February DOXORUBICIN HYDROCHLORIDE (delisting) Inj 50 mg vial Note Doxorubicin hydrochloride inj 50 mg vial to be delisted from 1 February AZACITIDINE (amended restriction) Inj 100 mg vial Vidaza Initiation Haematologist Re-assessment required after 12 months 1 Any of the following: 1.1 The patient has International Prognostic Scoring System (IPSS) intermediate-2 or high risk myelodysplastic syndrome; or 1.2 The patient has chronic myelomonocytic leukaemia (10%-29% marrow blasts without myeloproliferative disorder); or 1.3 The patient has acute myeloid leukaemia with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation Classification (WHO); and 2 The patient has performance status (WHO/ECOG) grade 0-2; and 3 The patient does not have secondary myelodysplastic syndrome resulting from chemical injury or prior treatment with chemotherapy and/or radiation for other diseases; and 4 The patient has an estimated life expectancy of at least 3 months. Notes: Indication marked with a * is an Unapproved Indication. Studies of temozolomide show that its benefit is predominantly in those patients with a good performance status (WHO grade 0 or 1 or Karnofsky score >80), and in patients who have had at least a partial resection of the tumour. Continuation Haematologist Re-assessment required after 12 months 1 No evidence of disease progression, and 2 The treatment remains appropriate and patient is benefitting from treatment. 18 Restriction (Brand) indicates a brand example only. It is not a contracted product.

19 Price Brand or 130 BORTEZOMIB (amended restriction) Inj 1 mg vial Velcade Inj 3.5 mg vial...1, Velcade Initiation treatment naive multiple myeloma/amyloidosis Re-assessment required after 15 months 1 Either: 1.1 The patient has treatment-naive symptomatic multiple myeloma; or 1.2 The patient has treatment-naive symptomatic systemic AL amyloidosis *; and 2 Maximum of 9 treatment cycles. Note: Indications marked with * are Unapproved Indications. Initiation relapsed/refractory multiple myeloma/amyloidosis Re-assessment required after 8 months 1 Either: 1.1 The patient has relapsed or refractory multiple myeloma; or 1.2 The patient has relapsed or refractory systemic AL amyloidosis *; and 2 The patient has received only one prior front line chemotherapy for multiple myeloma or amyloidosis; and 3 The patient has not had prior publicly funded treatment with bortezomib; and 4 Maximum of 4 treatment cycles. Note: Indications marked with * are Unapproved Indications. Continuation relapsed/refractory multiple myeloma/amyloidosis Re-assessment required after 8 months 1 The patient s disease obtained at least a partial response from treatment with bortezomib at the completion of cycle 4; and 2 Maximum of 4 further treatment cycles (making a total maximum of 8 consecutive treatment cycles). Notes: Responding relapsed/refractory multiple myeloma patients should receive no more than 2 additional cycles of treatment beyond the cycle at which a confirmed complete response was first achieved. A line of therapy is considered to comprise either: 1 A known therapeutic chemotherapy regimen and supportive treatments; or 2 A transplant induction chemotherapy regimen, stem cell transplantation and supportive treatments. Refer to datasheet for recommended dosage and number of doses of bortezomib per treatment cycle. 132 TEMOZOLOMIDE (amended restriction) Cap 5 mg 1% DV Sep-13 to Temaccord Cap 20 mg 1% DV Sep-13 to Temaccord Cap 100 mg 1% DV Sep-13 to Temaccord Cap 250 mg 1% DV Sep-13 to Temaccord 1 Either: 1.1 Patient has newly diagnosed glioblastoma multiforme; or 1.2 Patient has newly diagnosed anaplastic astrocytoma*; and 2 Temozolomide is to be (or has been) given concomitantly with radiotherapy; and 3 Following concomitant treatment temozolomide is to be used for a maximum of six cycles of 5 days treatment, at a maximum dose of 200 mg/m 2. Notes: Indication marked with a * is an Unapproved Indication. Temozolomide is not funded for the treatment of relapsed glioblastoma multiforme. Reapplications will not be approved. Studies of temozolomide Products with Hospital Supply Status (HSS) are in bold. Expiry date of HSS period is 30 June of the year indicated unless otherwise stated. 19

20 Price Brand or show that its benefit is predominantly in those patients with a good performance status (WHO grade 0 or 1 or Karnofsky score >80), and in patients who have had at least a partial resection of the tumour. 133 THALIDOMIDE (amended restriction) Cap 50 mg Thalomid Cap 100 mg Thalomid Initiation Re-assessment required after 12 months Any of the following: 1 The patient has multiple myeloma; or 2 The patient has systemic AL amyloidosis*; or 3 The patient has erythema nodosum leprosum. Continuation Patient has obtained a response from treatment during the initial approval period. Notes: Prescription must be written by a registered prescriber in the thalidomide risk management programme operated by the supplier. Maximum dose of 400 mg daily as monotherapy or in a combination therapy regimen. Indication marked with * is an Unapproved Indication 134 ERLOTINIB (amended restriction) Tab 100 mg 1% DV Jun-15 to , Tarceva Tab 150 mg 1% DV Jun-15 to , Tarceva Initiation Re-assessment required after 4 3 months Therapy limited to 3 months Either: Patient has locally advanced or metastatic, unresectable, non-squamous Non Small Cell Lung Cancer (NSCLC); and 1.2 There is documentation confirming that the disease expresses activating mutations of EGFR tyrosine kinase; and 1.3 Any of the following: Patient is treatment naive; or Patient has documented disease progression following treatment with first line platinum based chemotherapy; and Patient has not received prior treatment with gefitinib; or The patient has discontinued getitinib within 6 weeks of starting treatment due to intolerance; and The cancer did not progress while on gefitinib; and or 1.4 Erlotinib is to be given for a maximum of 3 months, or 2 The patient received funded erlotinib prior to 31 December 2013 and radiological assessment (preferably including CT scan) indicates NSCLC has not progressed. Continuation Re-assessment required after 6 months Therapy limited to 3 months Radiological assessment (preferably including CT scan) indicates NSCLC has not progressed. 20 Restriction (Brand) indicates a brand example only. It is not a contracted product.

21 Price Brand or 134 GEFITINIB (amended restriction) Tab 250 mg...1, Iressa Initiation Re-assessment required after 4 3 months Therapy limited to 3 months 1 Patient has locally advanced, or metastatic, unresectable, non-squamous Non Small Cell Lung Cancer (NSCLC); and 2 Either: 2.1 Patient is treatment naive; or The patient has discontinued erlotinib within 6 weeks of starting treatment due to intolerance; and The cancer did not progress whilst on erlotinib; and 3 There is documentation confirming that disease expresses activating mutations of EGFR tyrosine kinase. Continuation Re-assessment required after 6 months Therapy limited to 3 months Radiological assessment (preferably including CT scan) indicates NSCLC has not progressed. 134 IMATINIB MESILATE (amended restriction) Note: Imatinib-AFT is not a registered for the treatment of Gastro Intestinal Stromal Tumours (GIST). The Glivec brand of imatinib mesilate (supplied by Novartis) remains fully subsidised under Special Authority for patients with unresectable and/or metastatic malignant GIST, see SA1460 in Section B of the Pharmaceutical Schedule. Tab 100 mg...2, Glivec Initiation Re-assessment required after 12 months 1 Patient has diagnosis (confirmed by an oncologist) of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST); and 2 Maximum dose of 400 mg/day. Continuation Re-assessment required after 12 months Adequate clinical response to treatment with imatinib (prescriber determined). Note: The Glivec brand of imatinib mesilate (supplied by Novartis) remains fully subsidised under Special Authority for patients with unresectable and/or metastatic malignant GIST, see SA1460 in Section B of the Pharmaceutical Schedule. 137 SUNITINIB (amended restriction affected criteria only) Cap 12.5 mg...2, Sutent Cap 25 mg...4, Sutent Cap 50 mg...9, Sutent Initiation RCC Re-assessment required after 3 months 1 The patient has metastatic renal cell carcinoma; and 2 Any of the following: 2.1 The patient is treatment naive; or 2.2 The patient has only received prior cytokine treatment; or Products with Hospital Supply Status (HSS) are in bold. Expiry date of HSS period is 30 June of the year indicated unless otherwise stated. 21

22 Price Brand or 2.3 The patient has only received prior treatment with an investigational agent within the confines of a bona fide clinical trial which has Ethics Committee approval; or The patient has discontinued pazopanib within 3 months of starting treatment due to intolerance; and The cancer did not progress whilst on pazopanib; and 3 The patient has good performance status (WHO/ECOG grade 0-2); and 4 The disease is of predominant clear cell histology; and 5 The patient has intermediate or poor prognosis defined as any of the following: 5.1 Lactate dehydrogenase level > 1.5 times upper limit of normal; or 5.2 Haemoglobin level < lower limit of normal; or 5.3 Corrected serum calcium level > 10 mg/dl (2.5 mmol/l); or 5.4 Interval of < 1 year from original diagnosis to the start of systemic therapy; or 5.5 Karnofsky performance score of 70; or sites of organ metastasis; and 6 Sunitinib to be used for a maximum of 2 cycles. Notes: RCC Sunitinib treatment should be stopped if disease progresses. Poor prognosis patients are defined as having at least 3 of criteria Intermediate prognosis patients are defined as having 1 or 2 of criteria Continuation GIST Re-assessment required after 6 months The patient has responded to treatment or has stable disease as determined by Choi s modified CT response evaluation criteria as follows: 1 Any of the following: 1.1 The patient has had a complete response (disappearance of all lesions and no new lesions); or 1.2 The patient has had a partial response (a decrease in size of 10% or decrease in tumour density in Hounsfield Units (HU) of 15% on CT and no new lesions and no obvious progression of nonmeasurable disease); or 1.3 The patient has stable disease (does not meet criteria the two above) and does not have progressive disease and no symptomatic deterioration attributed to tumour progression; and 2 The treatment remains appropriate and the patient is benefiting from treatment. Notes: RCC Sunitinib treatment should be stopped if disease progresses. Poor prognosis patients are defined as having at least 3 of criteria Intermediate prognosis patients are defined as having 1 or 2 of criteria GIST It is recommended that response to treatment be assessed using Choi s modified CT response evaluation criteria (J Clin Oncol, 2007, 25: ). Progressive disease is defined as either: an increase in tumour size of 10% and not meeting criteria of partial response (PR) by tumour density (HU) on CT; or: new lesions, or new intratumoral nodules, or increase in the size of the existing intratumoral nodules. 141 ETANERCEPT (amended restriction affected criteria only) Inj 25 mg vial Enbrel Inj 50 mg autoinjector...1, Enbrel Inj 50 mg syringe...1, Enbrel Initiation adult-onset Still s disease Rheumatologist Re-assessment required after 6 months Either: Either: 22 Restriction (Brand) indicates a brand example only. It is not a contracted product.

23 Price Brand or The patient has had an initial Special Authority approval for etanercept for adult-onset Still s disease (AOSD); or The patient has been started on tocilizumab for AOSD in a DHB hospital in accordance with the Section H HML rules; and 1.2 Either: The patient has experienced intolerable side effects from adalimumab and/or tocilizumab; or The patient has received insufficient benefit from at least a three-month trial of adalimumab and/or tocilizumab such that they do not meet the renewal criteria for AOSD; or Patient diagnosed with AOSD according to the Yamaguchi criteria (J Rheumatol 1992;19: ); and 2.2 Patient has tried and not responded to at least 6 months of glucocorticosteroids, non-steroidal antiinflammatory drugs (NSAIDs) and methotrexate; and 2.3 Patient has persistent symptoms of disabling poorly controlled and active disease. 147 ADALIMUMAB (amended restriction affected criteria only) Inj 20 mg per 0.4 ml syringe...1, Humira Inj 40 mg per 0.8 ml pen...1, HumiraPen Inj 40 mg per 0.8 ml syringe...1, Humira Continuation rheumatoid arthritis Rheumatologist Re-assessment required after 6 months 1 Treatment is to be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance; and 2 Either: 2.1 Following 3 to 4 months initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or 2.2 On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; and 3 Adalimumab to be administered at doses no greater than 40 mg every 14 days 50 mg every 7 days. Initiation adult-onset Still s disease Rheumatologist Re-assessment required after 6 months Either: Either: The patient has had an initial Special Authority approval for etanercept for adult-onset Still s disease (AOSD); or The patient has been started on tocilizumab for AOSD in a DHB hospital in accordance with the Section H HML rules; and 1.2 Either: The patient has experienced intolerable side effects from etanercept and/or tocilizumab; or The patient has received insufficient benefit from at least a three-month trial of etanercept and/or tocilizumab such that they do not meet the renewal criteria for AOSD; or Patient diagnosed with AOSD according to the Yamaguchi criteria (J Rheumatol 1992;19: ); and 2.2 Patient has tried and not responded to at least 6 months of glucocorticosteroids, non-steroidal antiinflammatory drugs (NSAIDs) and methotrexate; and 2.3 Patient has persistent symptoms of disabling poorly controlled and active disease. Products with Hospital Supply Status (HSS) are in bold. Expiry date of HSS period is 30 June of the year indicated unless otherwise stated. 23

24 Price Brand or 154 INFLIXIMAB (amended restriction affected criteria only) Inj 100 mg 10% DV Mar-15 to 29 Feb Remicade Initiation rheumatoid arthritis Rheumatologist Re-assessment required after months 1 The patient has had an initial Special Authority approval for adalimumab and/or etanercept for rheumatoid arthritis; and 2 Either: 2.1 The patient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or 2.2 Following at least a four month trial of adalimumab and/or etanercept, the patient did not meet the renewal criteria for adalimumab and/or etanercept; and 3 Treatment is to be used as an adjunct to methotrexate therapy or monotherapy where use of methotrexate is limited by toxicity or intolerance. Initiation psoriatic arthritis Rheumatologist Re-assessment required after months 1 The patient has had an initial Special Authority approval for adalimumab and/or etanercept for psoriatic arthritis; and 2 Either: 2.1 The patient has experienced intolerable side effects from a reasonable trial of adalimumab and/or etanercept; or 2.2 Following 3-4 months initial treatment with adalimumab and/or etanercept, the patient did not meet the renewal criteria for adalimumab and/or etanercept for psoriatic arthritis. Continuation Crohn s disease (adults) Gastroenterologist Re-assessment required after 6 months Both 1 Any One of the following: 1.1 CDAI score has reduced by 100 points from the CDAI score when the patient was initiated on infliximab; or 1.2 CDAI score is 150 or less; or 1.3 The patient has demonstrated an adequate response to treatment but CDAI score cannot be assessed; and 2 Infliximab to be administered at doses up to 5 mg/kg every 8 weeks. Up to 10 mg/kg every 8 weeks (or equivalent) can be used for up to 3 doses if required for secondary non-response to treatment for reinduction. Another re-induction may be considered sixteen weeks after completing the last re-induction cycle; and 3 Patient must be reassessed for continuation after further 6 months. Continuation Crohn s disease (children) Gastroenterologist Re-assessment required after 6 months Both 1 Any One of the following: 1.1 PCDAI score has reduced by 10 points from the PCDAI score when the patient was initiated on infliximab; or 1.2 PCDAI score is 15 or less; or 24 Restriction (Brand) indicates a brand example only. It is not a contracted product.